Back to resultsFatigue and Cancer Treatment(FACT)- an Exercise Intervention
Primary Purpose
Cancer, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home based self paced walking program
Sponsored by
About this trial
This is an interventional other trial for Cancer focused on measuring Fatigue, Cancer treatment
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of cancer (Stage 1,2,or 3), 21 years of age or older, Free of cognitive or physical deficits that would preclude entry into study, not currently exercising 120 min/wk or more Exclusion Criteria: Concurrent major health problems or disabilities that would limit participation in an exercise program. Stage 4 cancer (metastisis)
Sites / Locations
- Johns Hopkins University School of Nursing
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00181129
First Posted
September 12, 2005
Last Updated
December 19, 2018
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00181129
Brief Title
Fatigue and Cancer Treatment(FACT)- an Exercise Intervention
Official Title
Mitigating Cancer Treatment-Related Fatigue by Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
5. Study Description
Brief Summary
The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Fatigue
Keywords
Fatigue, Cancer treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
home based self paced walking program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of cancer (Stage 1,2,or 3),
21 years of age or older,
Free of cognitive or physical deficits that would preclude entry into study,
not currently exercising 120 min/wk or more
Exclusion Criteria:
Concurrent major health problems or disabilities that would limit participation in an exercise program.
Stage 4 cancer (metastisis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria L Mock, DNSc
Organizational Affiliation
Johns Hopkins University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fatigue and Cancer Treatment(FACT)- an Exercise Intervention
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